The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial

Mara Fernandes Maranhão, Nara Mendes Estella, Maria Elisa Gisbert Cury, Veruska Lastoria Amigo, Clarissa Mollinero Picasso, Arthur Berberian, Iain Campbell, Ulrike Schmidt, Angélica Medeiros Claudino, Mara Fernandes Maranhão, Nara Mendes Estella, Maria Elisa Gisbert Cury, Veruska Lastoria Amigo, Clarissa Mollinero Picasso, Arthur Berberian, Iain Campbell, Ulrike Schmidt, Angélica Medeiros Claudino

Abstract

Background: Binge eating disorder is a new category in DSM-5 and highly associated with higher body mass index. The neural mechanisms that underlie binge eating are of great interest in order to improve treatment interventions. Brain mechanisms underlying drug and food craving are suggested to be similar: for example, both are reported to be associated with increased neural activity in the orbitofrontal and anterior cingulate cortex, and a diminished regulatory influence from lateral prefrontal circuits. Several studies have begun to assess the potential benefits of brain stimulation in reducing craving and addictive behaviors. Data from a study of a one-off session of transcranial magnetic stimulation in healthy women identified as strong cravers and of individuals with bulimic-type eating disorders, reported a reduction in food craving and binge eating episodes. This provides support for a more extensive investigation of the potential therapeutic benefits of transcranial magnetic stimulation. Lastly, brain imaging studies and a dimensional approach, will improve understanding of the neural correlates of the disorders and of the mode of action of transcranial magnetic stimulation.

Methods/design: Sixty eligible obese females, with binge eating disorder, will be randomly allocated to receive 20 sessions of transcranial magnetic stimulation intervention (n = 30) or the sham transcranial magnetic stimulation intervention (n = 30) scattered 3 days/week. Thirty eligible controls will complete the baseline assessment. The primary outcome (number of binge eating episodes) will be assed at each treatment sessions, and 8 weeks after intervention completion (follow-up). It is hypothesized that mean weekly binge-eating episodes will be reduced in the intervention group, compared to the sham group, and that the effect will be maintained at follow-up.

Discussion: Despite the severity associated with Binge Eating Disorder, there are limited treatment options. This study is an important step in the development of more effective treatments. Importantly, the study is the first to investigating binge eating disorder using a dimensional approach, by looking at the different aspects of the disorder, such as behavioral factors, biological factors, brain circuits and chemistry.

Trial registration: Clinical Trials NCT02180984 . Registered in July 2014.

Figures

Fig. 1
Fig. 1
A summary of the study design and participants flow during the study
Fig. 2
Fig. 2
Consort 2010 Flow Diagram

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